Comparison of Atomoxetine and Placebo in Children and Adolescents With ADHD and ODD

Lilly

Status and phase: Completed; Phase 3

Conditions: Attention Deficit Hyperactivity Disorder; Oppositional Defiant Disorder

Treatments: Drug: placebo; Drug: atomoxetine hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00191698

B4Z-MC-LYBX

7068

Details and patient eligibility

About

The purpose of this trial is to test the effectiveness of atomoxetine in treating symptoms of ODD in children with ADHD and ODD.

Enrollment: 226 patients

Sex: All

Ages: 6 to 12 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients are male or female outpatients who are at least 6 years of age and not more than 12 years of age at study entry.
• Patients must meet DSM-IV diagnostic criteria for ADHD and ODD.
• If other comorbid conditions are present, either the ADHD or the ODD diagnosis must be the patient's primary diagnosis.
• Patients must have laboratory results, including serum chemistries, hematology, and urinalysis showing no significant abnormalities.
• Patients must have an ECG performed at study entry that is absent of any abnormality that, in the opinion of the physician, should exclude the patient.

Exclusion criteria

• Patients who weigh less than 20 kg or greater than 60 kg at study entry.
• Patients who have a history of Bipolar I or II disorder, psychosis, or pervasive developmental disorder.
• Patients who have a current diagnosis of Major Depressive Disorder ([MDD]; with or without psychotic features), PTSD, or CDRS-R total raw score >40 at study entry.
• Patients with a history of any seizure disorder.
• Patients determined by the investigator to be at serious suicidal risk.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

---

226 participants in 2 patient groups, including a placebo group

A

Experimental group

Description:

Atomoxetine is administered at 1.2 mg/kg/day, PO for 8 weeks, followed by 1.2 or 2.4 mg/kg/day, PO for 4 weeks, open label administration can continue for up to one year

Treatment:

Drug: atomoxetine hydrochloride

B

Placebo Comparator group

Description:

Placebo is administered by mouth, daily for 8 weeks. After 8 weeks, those randomized to placebo may be titrated to 1.2 mg/kg/day atomoxetine for the remainder of the study up to one year

Treatment:

Drug: placebo